urea

Generic: urea

Labeler: biocomp pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name urea
Generic Name urea
Labeler biocomp pharma, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

urea 400 mg/g

Manufacturer
BioComp Pharma, Inc.

Identifiers & Regulatory

Product NDC 44523-617
Product ID 44523-617_4629c716-aa54-7dc4-e063-6294a90a3dec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2018-03-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 44523617
Hyphenated Format 44523-617

Supplemental Identifiers

RxCUI
198342
UPC
0344523617070 0344523617032
UNII
8W8T17847W

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name urea (source: ndc)
Generic Name urea (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (44523-617-01) / 28.35 g in 1 BOTTLE, PLASTIC
  • 85 g in 1 BOTTLE, PLASTIC (44523-617-03)
  • 198.4 g in 1 BOTTLE, PLASTIC (44523-617-07)
source: ndc

Packages (3)

44523-617-01 1 BOTTLE, PLASTIC in 1 CARTON (44523-617-01) / 28.35 g in 1 BOTTLE, PLASTIC 44523-617-03 85 g in 1 BOTTLE, PLASTIC (44523-617-03) 44523-617-07 198.4 g in 1 BOTTLE, PLASTIC (44523-617-07)

Ingredients (1)

urea (400 mg/g)

Linked Drug Pages (1)

UREA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4629c716-aa54-7dc4-e063-6294a90a3dec", "openfda": {"upc": ["0344523617070", "0344523617032"], "unii": ["8W8T17847W"], "rxcui": ["198342"], "spl_set_id": ["6774a5ef-9bb0-4e7a-e053-2a91aa0af47f"], "manufacturer_name": ["BioComp Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (44523-617-01)  / 28.35 g in 1 BOTTLE, PLASTIC", "package_ndc": "44523-617-01", "marketing_start_date": "20180315"}, {"sample": false, "description": "85 g in 1 BOTTLE, PLASTIC (44523-617-03)", "package_ndc": "44523-617-03", "marketing_start_date": "20180315"}, {"sample": false, "description": "198.4 g in 1 BOTTLE, PLASTIC (44523-617-07)", "package_ndc": "44523-617-07", "marketing_start_date": "20180315"}], "brand_name": "UREA", "product_id": "44523-617_4629c716-aa54-7dc4-e063-6294a90a3dec", "dosage_form": "CREAM", "product_ndc": "44523-617", "generic_name": "UREA", "labeler_name": "BioComp Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "UREA", "active_ingredients": [{"name": "UREA", "strength": "400 mg/g"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20180315", "listing_expiration_date": "20261231"}